None listed
Conditions
Interventions
Drug, Radiation : Regimen I (control arm) Radiation Therapy: (External pelvic standard radiation or IMRT)
Radiation Therapy: (External pelvic standard radiation or intensity-modulated radiotherapy (I
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Eligible Patients 1.Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical hysterectomy with pelvic lymphadenectomy. 2 Patients with the following characteristics (depth of stromal invasion and lymphovascular space involvement to be pathologically confirmed): 2.1 Positive capillary-lymphovascular space involvement and one of the following: • Deep third penetration • Middle third penetration, clinical tumor = 2 cm • Superficial third penetration, clinical tumor = 5 cm 2.2 Negative capillary-lymphatic space involvement: • Middle or deep third penetration, clinical tumor = 4 3. Patients must have adequate: 3.1 Hematologic function: ANC(absolute neutrophil count) = 1,500/mcl, platelets = 100,000/mcl 3.2 Renal function: creatinine = UNL(upper normal limit) or calculated creatinine clearance = 60 mL/min 3.3 Hepatic function: bilirubin = 1.5 x normal, alkaline phosphate and serum aspartate aminotransferase(SGOT) = 3 x normal 3.4 patient with performance status 0, 1, 2. 3.5 Patients should not be randomized less than 3 weeks post-surgery but will not be acceptable for randomization more than 8 weeks post-surgery. 3.6 Patients who have met the pre-entry requirements 3.7 Patients must have signed an approved informed consent and authorization permitting release of personal health information. 3.8 Patients must be = 18 years of age.
Exclusion criteria
Exclusion criteria: 1.Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine site or with positive surgical margins. 2. Patients with septicemia or severe infection. 3. Patients with intestinal obstruction or gastrointestinal bleeding. 4 Patients with postoperative fistula. 5 Patients with cervix cancer who have received any previous radiation or chemotherapy. 6 Patients whose circumstances do not permit completion of the study or the required follow-up. 7 Patients with renal abnormalities requiring modification of radiation field (pelvic kidney, renal transplant, etc). 8 Patients with Performance Status of 3 or 4. 9 Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Recurrence free survival and Overall Survival: Product-limit estimates according to the method of Kaplan and Meier and the one sided log-rank test ( a =0.05) will be used to compare survival endpoints (RFS and OS) between treatment arms.Gompertz hazard regression will be employed to evaluate relative risk (hazard ratio) and cure rates, adjusting for known prognostics factors. It is plausible to used the infamous Cox proportional hazard regression, the advantage of the Gompertz approach is its provision of estimates of the cure rate;Evaluation of Site(s) of Recurrence : The site(s) of first disease recurrence will be classified as: pelvic-only, extra-pelvic-only or pelvic-and-extra-pelvic and tabulated by treatment group. The test of the hypothesis that the probability of local failure is independent of randomized treatment will be assessed with Exact Logistic Regression adjusted know prognostic factor | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity analysis Adverse events will be graded according to the active version of CTCAE (Grades 0 - 5), but combining Grades 0, 1 and 2 data. In addition to displaying frequency of AdverseEvent for each grade category, significance of observed differences between treatment arms within each AE category (e.g. GU, GI HM will be analyzed using Fishers’ exact tes;Health related Quality of life (QOL):Health related quality of life (QOL) will be assessed using a one page form, made up of 52 questions: the functional assessment cancer therapy-cervix(FACT-Cx (42)), Neuro-toxicity questions (4), additional toxicity questions (5), and pain question (1). The pain question is scored using an 11 point integer scale (from 0 = no pain to 10 = the worst pain). All other questions are scored using a 5 point scale (0 = not at all; 1 = a little bit, 2 = somewhat; 3 = quite a bit; 4 = very much). | — |
Countries
Korea, Republic of
Contacts
Public ContactYOUNG KIM
Asan Medical Center
Outcome results
None listed